An Open Label Pilot Study of Transcranial Direct Current Stimulation in Adults With ADHD

Massachusetts General Hospital1 site in 1 country30 target enrollmentDecember 2015

ConditionsAttention Deficit Hyperactivity Disorder

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Attention Deficit Hyperactivity Disorder
Sponsor: Massachusetts General Hospital
Enrollment: 30
Locations: 1
Primary Endpoint: Adult ADHD Investigator Symptom Rating Scale (AISRS)
Status: Suspended
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this pilot study is to determine whether transcranial direct current stimulation safely and effectively improves symptoms of ADHD.

Registry

clinicaltrials.gov

Start Date

December 2015

End Date

August 2020

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Massachusetts General Hospital

Responsible Party

Principal Investigator

Craig B. Surman, MD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

Inclusion Criteria

•Male and female adults 18-65 years of age.
•A diagnosis of childhood onset ADHD, meeting the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) \[American Psychiatric Association, 2013\] criteria, including at least 5 moderate inattentive or impulsive-hyperactive symptoms, and onset of several symptoms of inattentive or of impulsive/hyperactive traits by the age of
•English-speaking.

Exclusion Criteria

•Current or past history of mental retardation, severe sensory impairment such as deafness or blindness, hypomania, mania, psychosis, suicidal or homicidal behavior.
•Current moderate to severe symptoms of a mental health condition other than ADHD, assessed using a clinical evaluation and the Adult Self Report Scale that, in the judgment of the investigator, may jeopardize subject safety or interfere with their ability to participate in the study. Specifically, this will include current clinical diagnosis of moderate to severe major depression, or a score on the depressive problem subscale of the ASRS that falls in the clinically significant range.
•Substance use disorder within the past 6 months.
•Any significant medical condition, that, in the judgment of the investigator, may jeopardize subject safety.
•Pregnant females.
•Inability or unwillingness to participate in study procedures.
•Contraindication to tDCS: history of epilepsy, metallic implants in the head and neck, brain stimulators, vagus nerve stimulators, VP shunt, or pacemakers.
•Skin conditions that may make the application of, treatment with, and removal of the tDCS hardware painful as per the discretion of the clinician.
•Current use of a medication considered to be therapeutic for ADHD. If a subject is taking a medication that is considered by study investigators to potentially treat ADHD (eg. a stimulant, atomoxetine, buproprion, modafanil, serotonin-norepinephrine reuptake inhibitor, guanfacine or clonidine) they must stop use of this medication for at least 5 half lives of the drug under physician guidance prior to study participation. Subjects will not enter the study if it would require stopping a medication that is optimally and comfortably managing a clinical concern.